Specialty Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan
Subject: Cimzia SGM 2005-A P2025
Drug
CIMZIA(certolizumab pegol)
Policy:
Indications
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indications1
Reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy
Treatment of adults with moderately to severely active rheumatoid arthritis
Treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older
Treatment of adults with active psoriatic arthritis
Treatment of adults with active ankylosing spondylitis
Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation
Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
Submission of the following information is necessary to initiate the prior authorization review:
Rheumatoid Arthritis (RA)
Initial requests
Chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable), including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.
Laboratory results, chart notes, or medical record documentation of biomarker testing (i.e., rheumatoid factor [RF], anti-cyclic citrullinated peptide [anti-CCP], and C-reactive protein [CRP] and/or erythrocyte sedimentation rate [ESR]) (if applicable).
Continuation requests
Chart notes or medical record documentation supporting positive clinical response.
Chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable), including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.
Continuation requests
Chart notes or medical record documentation supporting positive clinical response.
Crohn’s Disease (CD)
Continuation requests
Chart notes or medical record documentation supporting positive clinical response to therapy or remission.
Plaque Psoriasis (PsO)
Initial requests
Chart notes or medical record documentation of affected area(s) and body surface area (BSA) affected (if applicable).
Chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable), including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.
Continuation requests
Chart notes or medical record documentation of decreased body surface area (BSA) affected and/or improvement in signs and symptoms.
Prescriber Specialties
This medication must be prescribed by or in consultation with one of the following:
Psoriatic arthritis: rheumatologist or dermatologist
Crohn’s disease: gastroenterologist
Plaque psoriasis: dermatologist
Immune checkpoint inhibitor-related toxicity: oncologist, hematologist, or rheumatologist
Coverage Criteria
Rheumatoid Arthritis (RA)1,3-5,20,21,24
Authorization of 12 months may be granted for adult members who have previously received a biologic or targeted synthetic drug (e.g., Rinvoq, Xeljanz) indicated for moderately to severely active rheumatoid arthritis within the past 120 days.
Authorization of 12 months may be granted for adult members for treatment of moderately to severely active RA when both of the following criteria are met:
Member meets either of the following:
Member has been tested for either of the following biomarkers and the test was positive:
Rheumatoid factor (RF)
Anti-cyclic citrullinated peptide (anti-CCP)
Member has been tested for ALL of the following biomarkers:
RF
Anti-CCP
C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR)
Member meets ONE of the following:
Member has failed to achieve a low disease activity after a 3-month trial of methotrexate (MTX) monotherapy at a maximum titrated dose of at least 15 mg per week and meets any of the following conditions:
Member has had a documented inadequate response to MTX in combination with at least one other conventional synthetic drug (i.e., hydroxychloroquine and/or sulfasalazine) after a 3-month trial at a maximum tolerated dose(s).
Member has experienced a documented intolerable adverse event to hydroxycholorquine or sulfasalazine.
Member has a documented contraindication to hydroxychloroquine (see Appendix A) and sulfasalazine (e.g., porphyria, intestinal or urinary obstruction).
Member has moderate to high disease activity.
Member was unable to tolerate a 3-month trial of MTX monotherapy at a maximum titrated dose of at least 15 mg per week and meets any of the following conditions:
Member has had a documented inadequate response to MTX in combination with at least one other conventional synthetic drug (i.e., hydroxychloroquine and/or sulfasalazine) after a 3-month trial at a maximum tolerated dose(s).
Member has stopped taking MTX and has had a documented inadequate response to another conventional synthetic drug (i.e., leflunomide, hydroxychloroquine, and/or sulfasalazine) alone or in combination after a 3-month trial at a maximum tolerated dose(s).
Member has experienced a documented intolerable adverse event to leflunomide, hydroxychloroquine, or sulfasalazine.
Member has a documented contraindication to leflunomide, hydroxychloroquine (see Appendix A), and sulfasalazine (e.g., porphyria, intestinal or urinary obstruction).
Member has moderate to high disease activity.
Member has experienced a documented intolerable adverse event or has a documented contraindication to MTX (see Appendix A), discontinues MTX, and meets any of the following conditions:
Member has had a documented inadequate response to another conventional synthetic drug (i.e., leflunomide, hydroxychloroquine, and/or sulfasalazine) alone or in combination after a 3-month trial at a maximum tolerated dose(s).
Member has experienced a documented intolerable adverse event to leflunomide, hydroxychloroquine, or sulfasalazine.
Member has a documented contraindication to leflunomide, hydroxychloroquine (see Appendix A), and sulfasalazine (e.g., porphyria, intestinal or urinary obstruction).
Authorization of 12 months may be granted for members 2 years of age or older who have previously received a biologic or targeted synthetic drug (e.g., Xeljanz) indicated for moderately to severely active polyarticular juvenile idiopathic arthritis.
Authorization of 12 months may be granted for members 2 years of age or older for treatment of moderately to severely active polyarticular juvenile idiopathic arthritis when any of the following criteria is met:
Member has had an inadequate response to methotrexate or another conventional synthetic drug (e.g., leflunomide, sulfasalazine, hydroxychloroquine) administered at an adequate dose and duration.
Member has had an inadequate response to a trial of scheduled non-steroidal anti-inflammatory drugs (NSAIDs) and/or intra-articular glucocorticoids (e.g., triamcinolone hexacetonide) and has one of the following risk factors for poor outcome:
Member has risk factors for disease severity and potentially a more refractory disease course (see Appendix B) and meets one of the following:
High-risk joints are involved (e.g., cervical spine, wrist, or hip)
High disease activity
Is judged to be at high risk for disabling joint disease
Psoriatic Arthritis (PsA)1,6-9,17
Authorization of 12 months may be granted for adult members who have previously received a biologic or targeted synthetic drug (e.g., Rinvoq, Otezla) indicated for active psoriatic arthritis.
Authorization of 12 months may be granted for adult members for treatment of active psoriatic arthritis when either of the following criteria is met:
Member has mild to moderate disease and meets one of the following criteria:
Member has had an inadequate response to methotrexate, leflunomide, or another conventional synthetic drug (e.g., sulfasalazine) administered at an adequate dose and duration.
Member has an intolerance or contraindication to methotrexate or leflunomide (see Appendix A), or another conventional synthetic drug (e.g., sulfasalazine).
Member has enthesitis or predominantly axial disease.
Member has severe disease.
Ankylosing Spondylitis (AS) and Non-Radiographic Axial Spondyloarthritis (nr-axSpA)1,2,10-12
Authorization of 12 months may be granted for adult members who have previously received a biologic or targeted synthetic drug (e.g., Rinvoq, Xeljanz) indicated for active ankylosing spondylitis or active non-radiographic axial spondyloarthritis.
Authorization of 12 months may be granted for adult members for treatment of active ankylosing spondylitis or active non-radiographic axial spondyloarthritis when either of the following criteria is met:
Member has had an inadequate response to at least two non-steroidal anti-inflammatory drugs (NSAIDs).
Member has an intolerance or contraindication to two or more NSAIDs.
Crohn’s Disease (CD)1,13,14,22
Authorization of 12 months may be granted for treatment of moderately to severely active Crohn’s disease.
Plaque Psoriasis (PsO)1,6,9,15,18,19,23
Authorization of 12 months may be granted for adult members who have previously received a biologic or targeted synthetic drug (e.g., Sotyktu, Otezla) indicated for treatment of moderate to severe plaque psoriasis.
Authorization of 12 months may be granted for adult members for treatment of moderate to severe plaque psoriasis when any of the following criteria is met:
Crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affected.
At least 10% of body surface area (BSA) is affected.
At least 3% of body surface area (BSA) is affected and the member meets either of the following criteria:
Member has had an inadequate response or intolerance to either phototherapy (e.g., UVB, PUVA) or pharmacologic treatment with methotrexate, cyclosporine, or acitretin.
Member has a clinical reason to avoid pharmacologic treatment with methotrexate, cyclosporine, and acitretin (see Appendix A).
Immune Checkpoint Inhibitor-Related Toxicity25
Authorization of 12 months may be granted for treatment of immune checkpoint inhibitor-related toxicity when the member has moderate or severe immunotherapy-related inflammatory arthritis and meets either of the following:
Member has had an inadequate response to corticosteroids or a conventional synthetic drug (e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine).
Member has an intolerance or contraindication to corticosteroids and a conventional synthetic drug (e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine).
Continuation of Therapy
Rheumatoid Arthritis (RA)1,3-5,20,21,24
Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for moderately to severely active rheumatoid arthritis and who achieve or maintain a positive clinical response as evidenced by disease activity improvement of at least 20% from baseline in tender joint count, swollen joint count, pain, or disability.
Authorization of 12 months may be granted for all members 2 years of age or older (including new members) who are using the requested medication for moderately to severely active polyarticular juvenile idiopathic arthritis and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline:
Number of joints with active arthritis (e.g., swelling, pain, limitation of motion)
Number of joints with limitation of movement
Functional ability
Psoriatic Arthritis (PsA)1,6-9,17
Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for psoriatic arthritis and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline:
Number of swollen joints
Number of tender joints
Dactylitis
Enthesitis
Axial disease
Skin and/or nail involvement
Functional status
C-reactive protein (CRP)
Ankylosing Spondylitis (AS) and Non-Radiographic Axial Spondyloarthritis (nr-axSpA)1,2,10-12
Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for ankylosing spondylitis or non-radiographic axial spondyloarthritis and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline:
Functional status
Total spinal pain
Inflammation (e.g., morning stiffness)
Swollen joints
Tender joints
C-reactive protein (CRP)
Crohn’s Disease (CD)1,13,14,22
Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for moderately to severely active Crohn’s disease and who achieve or maintain remission.
Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for moderately to severely active Crohn’s disease and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline:
Abdominal pain or tenderness
Diarrhea
Body weight
Abdominal mass
Hematocrit
Appearance of the mucosa on endoscopy, computed tomography enterography (CTE), magnetic resonance enterography (MRE), or intestinal ultrasound
Improvement on a disease activity scoring tool (e.g., Crohn’s Disease Activity Index [CDAI] score)
Plaque Psoriasis (PsO)1,6,15,18,19,23
Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for moderate to severe plaque psoriasis and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when either of the following is met:
Reduction in body surface area (BSA) affected from baseline
Improvement in signs and symptoms from baseline (e.g., itching, redness, flaking, scaling, burning, cracking, pain)
Immune Checkpoint Inhibitor-Related Toxicity
Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for immunotherapy-related inflammatory arthritis and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition.
Other1,16
For all indications: Member has had a documented negative tuberculosis (TB) test (which can include a tuberculosis skin test [TST] or an interferon-release assay [IGRA]) within 12 months of initiating therapy for persons who are naïve to biologic drugs or targeted synthetic drugs associated with an increased risk of TB.
If the screening testing for TB is positive, there must be further testing to confirm there is no active disease (e.g., chest x-ray). Do not administer the requested medication to members with active TB infection. If there is latent disease, TB treatment must be started before initiation of the requested medication.
For all indications: Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication.
Dosage and Administration
Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.
Appendix
Appendix A: Examples of Clinical Reasons to Avoid Pharmacologic Treatment with Methotrexate, Hydroxychloroquine, Cyclosporine, Acitretin, or Leflunomide19
Clinical diagnosis of alcohol use disorder, alcoholic liver disease, or other chronic liver disease
Drug interaction
Risk of treatment-related toxicity
Pregnancy or currently planning pregnancy
Breastfeeding
Significant comorbidity prohibits use of systemic agents (e.g., liver or kidney disease, blood dyscrasias, uncontrolled hypertension)
Hypersensitivity
History of intolerance or adverse event
Appendix B: Risk Factors for Polyarticular Juvenile Idiopathic Arthritis
The above policy is based on the following references:
Cimzia [package insert]. Smyrna, GA: UCB, Inc.; September 2024.
van der Heijde D, Ramiro S, Landewe R, et al. 2016 Update of the international ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017;0:1-14.
Smolen JS, Landewé RBM, Bergstra SA, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023;82:3-18.
Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis 2016;68(1)1-26.
Saag KG, Teng GG, Patkar NM, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008;59(6):762-784.
Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 6: Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011;65(1):137-174.
Gossec L, Baraliakos X, Kerschbaumer A, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies; 2019 update. Ann Rheum Dis. 2020;79(6):700-712.
Gladman DD, Antoni C, Mease P, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005;64(Suppl II):ii14–ii17.
Coates LC, Soriano ER, Corp N, et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): updated treatment recommendations for psoriatic arthritis 2021. Nat Rev Rheumatol. 2022;18(8):465-479.
Braun J, van den Berg R, Baraliakos X, et al. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2011;70:896–904.
Landewe R, Braun J, Deodhar A, et al. Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study. Ann Rheum Dis. 2014;73(1):39-47.
Ward MM, Deodhar A, Gensler LS, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2019;71(10):1599-1613. doi:10.1002/art.41042.
Talley NJ, Abreu MT, Achkar J, et al. An evidence-based systematic review on medical therapies for inflammatory bowel disease. Am J Gastroenterol. 2011;106(Suppl 1):S2-S25.
Lichtenstein GR, Loftus EV, Afzali A, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol. 2025;120(6):1225-1264.
Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072.
Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Rheumatol. 2019;71(1):5-32. doi:10.1002/art.40726.
Menter A, Cordero KM, Davis DM, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis in pediatric patients. J Am Acad Dermatol. 2020;82(1):161-201.
Menter A, Gelfand JM, Connor C, et al. Joint AAD-NPF guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol. 2020;82(6):1445-86.
Aletaha D, Neogi T, Silman AJ, et al. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010;62(9):2569-81.
Smolen JS, Aletaha D. Assessment of rheumatoid arthritis activity in clinical trials and clinical practice. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. Available with subscription. URL: www.uptodate.com. Accessed March 19, 2021.
Scott FI, Ananthakrishnan AN, Click B, et al. AGA Living Clinical Practice Guideline on the Pharmacologic Management of Moderate-to-Severe Crohn's Disease. Gastroenterology. 2025;169(7):1397-1448.
Elmets C, Korman N, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol. 2021;84(2):432-470.
Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthrit Care Res. 2021;0:1-16.
Ringold S, Angeles-Han ST, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non-Systemic Polyarthritis, Sacroiliitis, and Enthesitis. Arthritis Care Res. 2019;71(6):717-734. doi:10.1002/acr.23870.
Onel KB, Horton DB, Lovell DJ, et al. 2021 American College of Rheumatology guideline for the treatment of juvenile idiopathic arthritis: therapeutic approaches for oligoarthritis, temporomandibular joint arthritis, and systemic juvenile idiopathic arthritis. Arthritis Rheumatol. 2022;74(4):553-569.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
